[Federal Register: September 13, 2006 (Volume 71, Number 177)]
[Notices]
[Page 54086-54087]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se06-102]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-06-0641]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Descriptive Epidemiology of Missed or Delayed Diagnoses for
Conditions Detected by Newborn Screening--(OMB No. 0920-0641)--
Extension-National Center for Environmental Health (NCEH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Every State in the United States and Washington, DC, has a public
health program to test newborn babies for congenital metabolic and
other disorders through laboratory testing of dried blood spots. These
programs screen for between 4 and 36 different conditions including
phenylketonuria (PKU) and congenital hypothroidism, with testing
performed in both state laboratories and private laboratories
contracted by state health departments. The screening process or system
is broader than the state public health newborn screening program,
which is composed only of the laboratory and follow-up personnel. It
involves the collection of blood from a newborn, analysis of the sample
in a screening laboratory, follow-up of abnormal results, confirmatory
testing and diagnostic work-up. Parents, hospitals, medical providers
including primary care providers and specialists, state laboratory and
follow-up personnel, advocates, as well as other partners such as local
health departments, police, child protection workers, and courts play
important roles in this process. Most children born with metabolic
disease are identified in a timely manner and within the parameters
defined by the newborn screening system of each State. These children
are referred for diagnosis and treatment. However, some cases are not
detected at all or the detection comes too late to prevent harm. These
``missed cases'' often result in severe morbidity such as mental
retardation or death.
In this project, we will update and expand a previous
epidemiological study of missed cases of two disorders published in
1986. We will assess the number of cases of each disorder missed, the
reasons for the miss and legal outcomes, if any. The reasons for the
miss will be tabulated according to which step or steps of the
screening process it occurred. Data will be collected by asking state
public health laboratory directors, newborn screening laboratory
managers, follow-up coordinators, specialists at metabolic clinics and
parent groups with an interest in newborn screening for information
regarding missed cases. An estimated 100 subjects will be requested to
complete a short questionnaire that asks for information regarding the
details of any missed cases of which they are aware.
The survey will highlight procedures and actions taken by States
and other participants in newborn screening systems to identify causes
of missed cases and to modify policies and procedures to prevent or
minimize recurrences. The information gleaned from this study may be
used to help craft changes in the screening protocols that will make
the process more organized and efficient and less likely to fail an
affected child. Further, it is not clear that there is a systematic
assessment of missed cases on a population basis; this project will
seek to identify procedures for routine surveillance of missed cases.
There are no costs to respondents except their time to participate in
the survey.
Estimated Annualized Burden Hours
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Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hours) (hours)
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State laboratory directors, screening laboratory 100 1 10/60 17
managers, follow-up coordinators, metabolic
clinic specialists, and parent groups..........
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[[Page 54087]]
Dated: September 7, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-15151 Filed 9-12-06; 8:45 am]
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